Characteristics of Included Publications

First Author,
Publication
Year, Country

Types and
numbers of
primary
studies
included

Population
Characteristics

Intervention

Comparator(s)

Clinical
Outcomes,
Length of
Follow-Up

Rombouts et. al., 2015,
Netherlands¹⁰

Other therapies were also included, but 4 studies (3 prospective cohorts and 1 retrospective cohort) examining IRE were included.

Patients with LAPC

Open IRE using the NanoKnife (3 studies, 130 patients)

Percutaneous IRE using the NanoKnife (1 study, 11 patients)

None

Overall complications, IRE related complications, overall mortality, IRE related mortality, median survival.

Follow-up not reported however, median survival indicates from 6 to 20 months.

Scheffer, 2014,
The Netherlands⁹

Liver tumors: 8 studies (1 prospective observational, 1 retrospective comparative, 3 retrospective observational, 3 case reports)^*

Pancreatic tumors: 4 studies (1 prospective comparative, 1 prospective observational, 1 retrospective observational, 1 case report)^*

Other tumors: 2 studies not relevant to the current review

Patients with liver tumors (HCC = 49 patients; colorectal liver metastases = 57; other = 23)

Patients with pancreatic adenocarcinoma (pancreatic head = 41 patients; body/tail = 27; uncinated process = 1)

(23 patients with other tumors also included but not relevant to the current review)

Median age ranged from 51 to 65 for liver cancer and 57 to 78 for pancreatic cancer.

Open IRE (4 studies, 115 patients)

Laparoscopic IRE (2 studies, 4 patients)

Percutaneous IRE (9 studies, 93 patients)

No IRE
No comparator

Morbidity
Mortality
Disease progression

First Author,
Publication
Year, Country,
Study Name

Study Design

Patient
Characteristics

Intervention(s)

Comparator(s)

Clinical
Outcomes

Pancreatic Cancer

Belfiore, 2015,
Italy¹¹

Prospective, non-comparative, before and after.

20 patients with LAPC;

mean age 69.2 years (range 55 to 82)

50% male

lesions ≤ 6 cm

IRE with NanoKnife (percutaneous, CT guided)

All patients also received chemotherapy

None

Complications, mortality, change in lesion volume.

Kluger, 2015,
USA¹²

Prospective non-comparative before and after

53 patients with LAPC; n = 29 primary, n = 24 margin extension

median age: 66.5 (IQR 60.2 to 72.0)

58.5% male

median tumor size: 3.0 cm (IQR 1.7 to 5.0)

IRE with NanoKnife

(all patients also received chemotherapy and/or radiation)

None

Primary: 90 day Clavien–Dindo complications

Secondary: survival, recurrence

Martin, 2015,
USA¹⁴

Retrospective database review

Patients with LAPC who had been treated with chemotherapy, chemoradiation, or both. (N = 200)

median age 62 years (range: 27 to 88)

50% male

median tumor size: 2.8 cm (longest axis)

62% white, low Charleston comorbidity index, low frailty index.

IRE with NanoKnife performed during resection.

IRE with NanoKnife performed alone (unresectable patients)

All IRE procedures were open surgery.

n = 50 patients had IRE for margin extension

n = 150 patients in situ

None

Recurrence using RECIST criteria

Adverse events

Progression-free survival

Paiella, 2015,
Italy¹³

Prospective, non-comparative, before and after

10 patients with unresectable, non- metastatic, LAPC

mean age 66 years

40% male

Tumor size <4 cm

mean follow up: 7.6 months

IRE with NanoKnife

None

Complications AEs

Response (RECIST criteria)

Kwon, 2014,
USA¹⁵

Retrospective , non-comparative, database review

48 patients with borderline resectable or LAPC.

Median age: 61 (range 27 to 81)

54% male

mean tumor size: 3.5 cm

IRE with NanoKnife (open surgery)

patients were treated initially with chemotherapy and chemoradiation

None

Complications

90 day response (RECIST criteria)

Liver Cancer

Dollinger, 2015,
Germany²²

Retrospective database review

Patients with non-resectable liver tumors that were not suitable for thermal ablation.
N = 52 (n = 28 with primary tumors; n = 28 with secondary tumors)

75% male

median age 61 years (range, 22 to 81 years)

IRE with NanoKnife (percutaneous)

median number of IRE sessions per patient was 1 (range, 1 to 4).

median procedure time 172 min (range, 55 to 561 min

None

Complications

Eller, 2015,
Germany²⁴

Prospective, non-comparative before and after

14 patients with liver cancer (3 with HCC and 11 with hepatic metastases

86% male

mean age: 58 SD 11 years

IRE with NanoKnife (percutaneous)

None

Adverse Events

Recurrence

Granata, 2015,
Italy¹⁶^,¹⁷

Prospective, non-comparative before and after (non- consecutive sample)

Patients with unresectable HCC (N = 20) Tumor size ≤3 cm

60% male

mean age: 65 (range 48 to 80)

IRE (percutaneous)

all patients underwent imaging for monitoring

None

Response as determined by imaging and RECIST guidelines.

Sugimoto, 2015,
Japan²⁰

Prospective, non-comparative, before and after.

5 patients with unresectable HCC.

60% male

mean age 66.6 years ± 5.8

IRE using NanoKnife (percutaneous)

None

Tumor response

Safety

Eisele, 2014,
Germany¹⁹

Prospective, non-comparative, before and after.

14 patients with liver tumors (HCC, CRLM, CCC)

69% male

mean age 63 years

IRE using NanoKnife (percutaneous n = 7; lapaproscopic n = 4; open surgery n = 2)

None

Recurrence

Adverse events

Dollinger, 2014,
Germany²³

Retrospective, non-comparative review

34 patients (with 52 tumors; 30 primary tumors, 22 hepatic metasteses)

82% male

mean age 64 years (range 22 to 80)

IRE with NanoKnife (percutaneous)

None

Adverse events

Scheffer, 2014,
Netherlands,¹⁸
COLDFIRE-I

Prospective, non-comparative, before and after.

10 patients with CRLM

40% male

mean age: 63 (49 to 74)

2 patients had not received systemic chemotherapy

lesion size: 2.4 cm (0.8 to 5.3)

IRE with NanoKnife (laparoscopic)

None

Adverse events

Hosein, 2014,
USA²¹

Retrospective non-comparative, before and after

29 patients with CRLM unresectable (70% had IRE as a sole modality of treatment, 20% as part of multi-modal treatment, 10% as palliative treatment) median age: 62 years

IRE with NanoKnife (percutaneous)

None

Survival

Complications

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Bookshelf ID: NBK350615

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Irreversible Electroporation for Tumors of the Pancreas or Liver: A Review of Clinical and Cost-Effectiveness [Internet].

APPENDIX 2Characteristics of Included Publications

Table A1Characteristics of Included Systematic Reviews and Meta-Analyses

Table A2Characteristics of Included Clinical Studies

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